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FDA 510(k)

STERILE ESMARCH BANDAGE

K-Number: K881176 · 1988-04-11

ApplicantSpectrum/Hydro-Med Products, Inc.
Decision Date1988-04-11
Product CodeGAX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE ESMARCH BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum/Hydro-Med Products, Inc.. It received FDA 510(k) clearance on 1988-04-11 under 510(k) number K881176. The device is classified under product code GAX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE ESMARCH BANDAGE?

STERILE ESMARCH BANDAGE is a medical device that received FDA 510(k) clearance on 1988-04-11. The listed applicant is Spectrum/Hydro-Med Products, Inc.. The 510(k) number is K881176.

When did STERILE ESMARCH BANDAGE receive FDA 510(k) clearance?

STERILE ESMARCH BANDAGE received FDA 510(k) clearance on 1988-04-11, under 510(k) number K881176.

Who is the listed applicant for STERILE ESMARCH BANDAGE?

The FDA 510(k) record lists Spectrum/Hydro-Med Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE ESMARCH BANDAGE?

The FDA product code for STERILE ESMARCH BANDAGE is GAX.

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Related Devices (Code: GAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K931198UNIQUETIcat SystemsK881398TOURNIQUETBarretta Products, Research and Development, Inc.K875092DEGANIA SILICONE TOURNIQUETDegania Silicone , Ltd.K873928UNIVERSAL TOURNIQUETDryden Corp.K872003KINDERWRAPThe Kinder Co.K864897DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335Dale Medical Products, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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